A Phase 3 Randomized, Open-Label, Multicenter Study of Sonrotoclax Plus Anti-CD20 Antibody Therapies Versus Venetoclax Plus Rituximab in Patients With Relapsed/Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma SONROTOCLAX COMBINATION THERAPY

What's the purpose of this trial?

The goal of this study is to compare how well sonrotoclax plus obinutuzumab works versus venetoclax plus rituximab in treating adults with relapsed and/or refractory (R/R) chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL). The study will also compare how well sonrotoclax plus rituximab works versus venetoclax plus rituxumab in treating adults with R/R CLL/SLL. The safety of these treatments will also be assessed.

This trial is currently open and accepting patients.

You may be able to join this trial if you:

The following criteria is a partial list of reasons why patients may be eligible to participate in this clinical trial. Further evaluation with a medical professional is required.

Inclusion Criteria:

* Confirmed diagnosis of CLL/SLL that meets the International Workshop on Chronic Lymphocytic Leukemia (iwCLL) criteria
* Received one or more prior therapies for CLL/SLL. For each line of therapy, participants must have received at least 2 cycles of the therapy
* Participants with prior BCL2i exposure are eligible if remission duration was ≥3 years with ≥2 years from last BCL2i intake
* Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0, 1, or 2
* Adequate organ function

Exclusion Criteria:

* Known active prolymphocytic leukemia or currently suspected Richter's transformation
* Prior autologous stem cell transplantation or chimeric antigen receptor T-cell therapy within 3 months before first dose of study drug
* Prior allogeneic stem cell transplant with active graft-versus-host disease (GVHD), requiring immunosuppressive drugs for treatment of GVHD, or have taken calcineurin inhibitors within 4 weeks prior to consent
* Known central nervous system involvement by CLL/SLL
* Severe or debilitating pulmonary disease
* Clinically significant cardiovascular disease

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Additional Trial Information

Phase 3

Enrollment: 630 patients (estimated)

View More
Need Help?

Interested in joining or learning more about this trial?

(888) 828-2206

Trial Locations

All Trial Locations

View all clinical trial locations sorted by state.

California

Chao Family Comprehensive Cancer Center University of California, Irvine

Orange, CA

Open and Accepting

Scripps Prebys Cancer Center

San Diego, CA

Open and Accepting

Stanford University Cancer Institute (Palo Alto)

Stanford, CA

Open and Accepting

Colorado

Rocky Mountain Cancer Centers

Aurora, CO

Open and Accepting

Connecticut

Smilow Cancer Hospital at Yale New Haven

New Haven, CT

Open and Accepting

Eastern Connecticut Hematology and Oncology Associates

Norwich, CT

Open and Accepting

Illinois

Robert H. Lurie Comprehensive Cancer Center Northwestern University Feinberg School of Medicine

Chicago, IL

Open and Accepting

Illinois Cancer Specialists

Niles, IL

Open and Accepting

Louisiana

Mary Bird Perkins Cancer Center

Baton Rouge, LA

Open and Accepting

Maryland

University of Maryland Medical Center Marlene and Stewart Greenebaum Comprehensive Cancer Center

Baltimore, MD

Open and Accepting

Massachusetts

Dana-Farber Cancer Institute

Boston, MA

Open and Accepting

Michigan

Cancer and Hematology Centers of Western Michigan - East

Grand Rapids, MI

Open and Accepting

Minnesota

Mayo Clinic (Rochester)

Rochester, MN

Open and Accepting

New Jersey

Memorial Sloan Kettering Basking Ridge

Basking Ridge, NJ

Open and Accepting

Memorial Sloan Kettering Monmouth

Middletown, NJ

Open and Accepting

Memorial Sloan Kettering Bergen

Montvale, NJ

Open and Accepting

New York

Memorial Sloan Kettering Cancer Center

New York, NY

Open and Accepting

Memorial Sloan Kettering Commack

Commack, NY

Open and Accepting

Memorial Sloan Kettering Nassau

Uniondale, NY

Open and Accepting

Memorial Sloan Kettering Westchester

West Harrison, NY

Open and Accepting

North Carolina

UNC Lineberger Comprehensive Cancer Center University of North Carolina

Chapel Hill, NC

Open and Accepting

Atrium Health's Levine Cancer Institute - Charlotte (Main) Atrium Health

Charlotte, NC

Open and Accepting

Ohio

Oncology Hematology Care, Inc. - Blue Ash

Cincinnati, OH

Open and Accepting

Oregon

Oncology Associates of Oregon

Eugene, OR

Open and Accepting

Pennsylvania

Penn State Hershey Medical Center

Hershey, PA

Open and Accepting

UPMC Hillman Cancer Center University of Pittsburgh Medical Center (UPMC)

Pittsburgh, PA

Open and Accepting

Tennessee

Tennessee Oncology

Dickson, TN

Open and Accepting

Texas

Texas Oncology - Sammons Cancer Center

Dallas, TX

Open and Accepting

Texas Oncology - San Antonio Medical Center

San Antonio, TX

Open and Accepting

Texas Oncology

Tyler, TX

Open and Accepting

Washington

Northwest Cancer Specialists, P.C.

Vancouver, WA

Open and Accepting
Interested in this trial?
  • Call us today 😀 keyboard_arrow_right

    We know how difficult and confusing this process can be. If you are interested in this clinical trial or have questions, you can call us at any time. You can also send us a direct message with questions.

    (888) 828-2206
  • Add this trial to your favorites keyboard_arrow_right

    If you are interested in keeping an eye on this trial, you can add it to your list of favorite trials. We'll send you alerts when this trial is updated.

  • Talk to your doctor keyboard_arrow_right

    You can print an overview of this trial to take in to your next appointment. Your doctor can help you understand if this trial may be right for you.

Still need help? Send us a message